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Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

This study has been terminated.
Information provided by (Responsible Party):
UCB Pharma Identifier:
First received: June 10, 2005
Last updated: March 30, 2012
Last verified: March 2012
The goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE.

Condition Intervention Phase
Lupus Erythematosus, Systemic Drug: epratuzumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus Erythematosus

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters.

Secondary Outcome Measures:
  • Evaluation of pharmacokinetic samples to assess immunogenicity and evaluation of post-treatment BILAG scores for initial efficacy and disease variability.

Estimated Enrollment: 20
Study Start Date: April 2005
Study Completion Date: June 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:
This study is planned to provide information on how the body processes epratuzumab and how epratuzumab affects the body when epratuzumab is given once weekly for 4 weeks in a row at one of 2 different dose levels. Additional information will be obtained related to the natural variability of disease activity in SLE patients.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has SLE by American College of Rheumatology revised criteria (meets >/= 4 criteria)
  • Has had SLE for at least 6 months prior to study entry
  • Has at least one elevated autoantibody level at study entry
  • Has moderately active SLE disease at study entry in any body/organ system (Full criteria not present here due to length of considerations. The protocols should be consulted regarding the complete list of entry criteria.)

Exclusion criteria:

  • Active Severe Lupus as defined by BILAG Index Level A in any body system or organ
  • Allergy to human antibodies or Murine
  • Prior therapy with other anti-B cell antibodies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00113971

United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Lupus Center of Excellence
Pittsburgh, Pennsylvania, United States, 15261
United States, South Carolina
Rheumatology Associates
Charleston, South Carolina, United States, 29407
Sponsors and Collaborators
UCB Pharma
Study Director: Anna Barry UCB Pharma
  More Information

Kaufmann J, Wegener WA, Horak ID, et al. Pilot clinical trial of epratuzumab (humanized anti-CD22 antibody) for immunotherapy in systemic lupus erythematosus (SLE) [abstract]. Ann Rheum Dis 2004; 63 (suppl I): Thu0443. (Published online at

Responsible Party: UCB Pharma Identifier: NCT00113971     History of Changes
Other Study ID Numbers: SL0002 (IMMU-103-SLE-02)
Study First Received: June 10, 2005
Last Updated: March 30, 2012

Keywords provided by UCB Pharma:
study of epratuzumab in systemic lupus erythematosus
systemic lupus erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on September 21, 2017